BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS

    MDR report key: 1600597 · Received February 3, 2010

    Report

    Report Number
    1600597
    Event Type
    Malfunction
    Date Received
    February 3, 2010
    Date of Event
    January 27, 2010
    Report Date
    January 27, 2010
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIVISION
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    SURGEON PERFORMING ARTHROSCOPY OF PATIENT'S RIGHT ANKLE USING 2 DIFFERENT DYONICS ARTHROSCOPIC SURGERY BLADES. ONE NOTED TO DISINTEGRATE UPON USE (SHAVINGS VISIBLE ON VIDEO MONITOR) AND ANOTHER APPEARED TO BE WINDING TIGHTLY WHEN END OF SHAVER OUTSIDE PATIENT SNAPPED OFF. INSTRUMENTS WERE REPLACED AND SURGERY COMPLETED WITHOUT APPARENT INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS SHAVER, ABRADER HRX SMITH & NEPHEW INC., ENDOSCOPY DIVISION * *
    2 DYONICS SHAVER, BLADE, FULL RADIUS HRX SMITH & NEPHEW INC., ENDOSCOPY DIVISION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *